The U.S. FDA has approved Merck's Lipfendra, the first oral PCSK9 inhibitor pill for high cholesterol. Priced at $10.50 per day, the once-daily drug reduced "bad" LDL cholesterol by up to 60% in trials. The approval provides a new treatment alternative to injectables and helps Merck diversify its portfolio as its blockbuster cancer drug, Keytruda, faces patent expiration in 2028.
FDA approval for Lipfendra
- ▪Lipfendra is a once-daily pill intended to treat hypercholesterolemia, which is identified by elevated levels of LDL or "bad" cholesterol
- ▪The FDA's approval was based on two late-stage trials that showed the pill significantly lowered LDL cholesterol in patients, including those already taking statins
- ▪The U.S. Food and Drug Administration (FDA) approved Merck's cholesterol pill, Lipfendra, on July 16, 2026
- ▪In clinical studies, Lipfendra reduced bad LDL cholesterol levels by up to 60% over six months in adults with or at risk for atherosclerotic cardiovascular disease
PCSK9 inhibitor mechanism
- ▪According to the American Heart Association, about one in four adults in the U.S. have high LDL cholesterol
- ▪Lipfendra is the first oral PCSK9 inhibitor to be approved and enter the market
- ▪The drug works by blocking the PCSK9 protein, which plays a vital role in regulating cholesterol levels
- ▪This mechanism differs from oral statins, which block an enzyme the liver uses to make cholesterol
Merck portfolio diversification
- ▪Keytruda is set to lose key patent protections starting in 2028, exposing Merck to competition from less expensive biosimilar versions
- ▪The approval of Lipfendra helps Merck diversify its portfolio beyond its blockbuster cancer drug, Keytruda
Daily list price
- ▪The list price for Lipfendra will be $10.50 per day, based on a 30-day supply
- ▪Merck will sell Lipfendra for about $3,800 a year
Peak sales potential
- ▪Following the approval announcement, Merck's shares rose 1.1% in premarket trading
- ▪A Scotiabank analyst projected Lipfendra could have "peak sales potential of tens of billions of dollars."
Competitive injectable alternatives
- ▪Lipfendra provides an oral alternative to a class of cholesterol-lowering drugs long dominated by injectables
- ▪The market for PCSK9-inhibitor drugs is currently dominated by injectables like Amgen's Repatha and Regeneron and Sanofi's Praluent
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